K905306 is an FDA 510(k) clearance for the MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN. This device is classified as a Antigen, Cf (including Cf Control), Mumps Virus (Class I - General Controls, product code GRC).
Submitted by Virion (U.S.), Inc. (Morristown, US). The FDA issued a Cleared decision on June 17, 1991, 201 days after receiving the submission on November 28, 1990.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3380.
| 510(k) Number | K905306 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 1990 |
| Decision Date | June 17, 1991 |
| Days to Decision | 201 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GRC — Antigen, Cf (including Cf Control), Mumps Virus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3380 |